Jargon: We use it every day.
Within our teams we can speak in our own language, the day to day talk that becomes embedded in our group consciousness.
The life sciences and medical industry as a whole is rife with specialist terminology, but outside our own bubble this has the propensity to confound and even alienate if we're not aware of the audience we're talking to.
In this blog I'll be attempting to demystify some common industry terms and acronyms that frequently come up.
Common Acronyms - Products/Manufacturing
COA/C of A - Certificate Of Analysis. A commonly supplied information sheet with biological products typically detailing the composition, concentrations, expiry and other key information about a supplied product or kit.
IFU - Instructions For Use. Usually associated with a test kit or multiple part product, an IFU can often be supplied with similar details to a C of A, but also including some application or protocol type instruction in the use of the product. It is not unusual for an IFU to be supplied in place of a C of A for single vial reagents.
IVD - In Vitro Diagnostic. This term describes the usage of a medical test or device that can diagnose, detect or monitor an ailment using a sample from an affected patient.
MD - Medical Device. A medical device is defined as an article prescribed for a medical use by the manufacturer. This can range from an implantable device such as a pacemaker, to a blood glucose meter commonly carried by diabetes sufferers or a test kit to diagnose an illness using a patient sample.
OEM - Original Equipment Manufacturer. Within the Life Sciences arena this typically means a company that produces products that are sold for other companies to remarket or sell on relabelled as their own.
SDS/MSDS - Safety Data Sheet/Material Safety Data Sheet. Required by REACH legislation on chemicals within the EU, safety data sheets are a way of recording the chemical components of a product and their associated risks at their working concentrations.
QC - Quality Control. This is the method by which a product is assessed as suitable for release or sale, with the method of assessment used usually detailed in an accompanying C of A or IFU.
Common Acronyms - Business/Quality
CRO - Contract Research Organisation/Clinical Research Organisation. These types of organisations often work within the pharmaceutical industry as an outsource for work relating to research and development, clinical trials, product development and other areas.
ERP/MRP - Enterprise/Materials Resource Planning. This is management software used by many types of business to assist in the day to day running of the business covering aspects such as stock holding, workloads, human resources, documentation and many other areas.
GMP - Good Manufacturing Practice. This is a set of guidelines and principles used to help achieve to the standards required to manufacture medical devices and assay components used within the medical industry.
ISO - International Standards Organisation. You may be familiar with seeing this as a prefix with a set of numbers accompanying, for example ISO9001. These agreed international standards cross many industries, with the numbers being specific to the industry process they relate to.
RA - Regulatory Affairs. Within organisations this is usually the department or group responsible for guidance and adherence to the specific regulations and laws related to the products or services offered.
QA - Quality Assurance. The overall term for systematic checking of a company's output to meeting a desired standard of quality. Often this involves external accreditation, such as ISO standards, in tandem with documented and monitored processes and practices.
Analyte - A substance, be it protein or chemical which is the subject of an analysis or measurement.
In vitro - This Latin-origin term refers to something being outside of the body or natural environment. In the medical industry this generally refers to a test involving a patient sample being performed in a laboratory environment.
In vivo - As a counterpoint to the above definition, this refers to being within the body or natural environment, and usually refers to a treatment or test that is invasive to the patient.
Life Science - The group of sciences focused on biological life. Rooted in biology it also crosses over into other fields such as molecular chemistry.
Monoclonal - Monoclonal antibodies are those secreted from a single B cell, so only recognise a singular epitope to a disease antigen.
Native - This most commonly refers to an antigen in it's unaltered, or natural form as opposed to a denatured or altered or recombinant antigen.
Polyclonal - Polyclonal antibodies are a collection of antibodies secreted from multiple B cells with each antibody recognising a different epitope on a single disease antigen.
Recombinant - In relation to recombinant antigens this defines the antigen as artificially produced, often by E. Coli expression.
Specificity - Within our industry this refers to the level of selectivity of reaction or interaction between or to a target. For example the selectivity of an antibody to antigen.
Sensitivity - This refers to the perceptible usage range of a reagent or test kit.
Titre/Titer - This is a way of expressing concentration. Titre/titer corresponds to the highest dilution factor that still generates a positive result. In an immunology setting this typically means the dilution at which an antibody is still capable of binding to the appropriate antigen to a measurable level.
IgG Fractionation/IgG Fraction - A type of protein purification, where the physical conditions of the material are altered to precipitate proteins out of solution, leaving the immunoglobulins, or the IgG Fraction.
Affinity Purification/Affinity Purified - Another method of protein purification where a target protein is selected by affinity to an antigen target which is bound to a medium. When the selected proteins are eluted from the medium this leaves a protein highly specific to the target antigen, an affinity purified protein.
I hope this has helped explain some of the widespread, but nonetheless potentially confusing, terms that are often used our line of work.
Was there anything missing from this list? Or any terms you would like expanding upon?
Let us know by getting in touch with our team!
At Binding Site's Immunologicals Group we try and give our customers the most information we can on our products, providing transparency about their functionality and potential uses. Whether you are a researcher or global manufacturer we want to understand your application and only offer a suitable solution.
We provide product datasheets for many of our products with detailed information on the tests performed, and often customise our range to a customer's specific application.
Check out our range of antibodies, antigens and other reagents HERE.
Written by Andy Whitehouse, Immunologicals Product Manager